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Study of Pembrolizumab and Cabozantinib for Patients with Advanced Sarcomas: Undifferentiated Pleomorphic Sarcoma, Osteosarcoma, and Ewing Sarcoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a combination of two medications, pembrolizumab and cabozantinib, in patients with advanced forms of a type of cancer called sarcoma. Sarcomas are cancers that can occur in various tissues like bone or muscle. The specific types of sarcoma being studied in this trial are undifferentiated pleomorphic sarcoma, osteosarcoma, and Ewing sarcoma. Pembrolizumab is a medication that helps the immune system fight cancer cells, while cabozantinib is a drug that blocks certain proteins that help cancer cells grow.

The purpose of this study is to see how well these medications work together in stopping the progression of these sarcomas over a period of six months. Participants in the study will receive pembrolizumab as an infusion, which means it is given directly into the bloodstream through a vein, and cabozantinib as a tablet taken by mouth. The study will last for up to 24 months, during which time the participants will be monitored regularly to assess the effects of the treatment on their cancer.

Throughout the study, doctors will use imaging techniques like MRI or CT scans to check the size of the tumors and see if they are responding to the treatment. The study aims to determine if the combination of pembrolizumab and cabozantinib can help control the disease and improve the quality of life for patients with these advanced sarcomas. Participants will also be monitored for any side effects from the medications to ensure their safety during the trial.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Upon joining the study, the patient will begin the initial treatment phase. This involves receiving two medications: pembrolizumab and cabozantinib.
Pembrolizumab is administered through an intravenous infusion. This means the medication is given directly into a vein. The dosage is 25 mg/mL, and the frequency and duration will be determined by the study protocol.
Cabozantinib is taken orally in the form of film-coated tablets. The patient will take two different dosages: 20 mg and 40 mg tablets. The exact dosage and frequency will be specified by the study team.
Step 2
Ongoing monitoring
Throughout the trial, the patient's health and response to the treatment will be closely monitored. This includes regular medical check-ups and tests to assess the effectiveness of the treatment and to identify any side effects.
The patient will undergo imaging tests, such as CT scans or MRIs, to evaluate the progression of the disease. These tests will help determine if the treatment is working as expected.
Step 3
Biomarker analysis
During the trial, blood samples will be collected at specific time points to analyze various biomarkers. Biomarkers are substances in the body that can provide information about the disease and the effects of the treatment.
The analysis will include measuring levels of certain proteins and cells in the blood, which can help understand the body's response to the treatment.
Step 4
Tissue sampling
At the beginning of the trial, a sample of the tumor tissue will be collected. This sample will be used for detailed analysis to understand the characteristics of the tumor.
An optional second tissue sample may be collected during the treatment phase, with the patient's agreement. This will help in further understanding the effects of the treatment on the tumor.
Step 5
End of treatment evaluation
At the end of the treatment period, the patient's overall response to the treatment will be evaluated. This includes assessing whether the disease has progressed, stabilized, or improved.
The results of this evaluation will help determine the next steps in the patient's care and provide valuable information for the study.

Who can join the trial?

19 criteria

Must have a confirmed diagnosis of one of the following: undifferentiated pleomorphic sarcoma, osteosarcoma, or Ewing sarcoma.
Life expectancy must be more than 3 months.
Must have advanced disease and not be eligible for other treatments that are known to provide significant benefit.
No symptoms of disease in the central nervous system (brain and spinal cord).
Must not be using glucocorticoids (a type of steroid medication) regularly.
Must have adequate blood, kidney, liver, and metabolic function, as determined by specific medical tests.
No other cancer diagnosed or treated in the last 2 years, except for certain types of skin cancer or cervical cancer that have been treated.
At least three weeks must have passed since the last chemotherapy or immunotherapy, and two weeks for any other treatment or radiation therapy.
Must have recovered from any side effects of previous treatments to a certain level, except for hair loss, mild nerve pain, or mild hormone-related issues.
Women who can have children must have a negative pregnancy test before starting the study and agree to use two forms of birth control during the study and for 6 months after.
Must voluntarily sign a consent form to participate in the study.
Must have advanced disease that cannot be surgically removed or has spread to other parts of the body.
Must have experienced disease recurrence or progression after standard therapy.
Must have documented disease progression according to specific criteria, confirmed by two radiological assessments (like CT scans or MRI) within a certain timeframe.
Must provide a sample of tumor tissue that is less than 3 months old or from a new biopsy.
No more than three previous lines of systemic therapy for advanced disease.
Must be 18 years of age or older.
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures daily living abilities.
Must have measurable disease according to specific criteria, with at least one tumor that is 10 mm or larger.

Who cannot join the trial?

10 criteria

Patients with other types of cancer that are not the specific sarcomas being studied.
Patients who have had another cancer treatment within a certain time frame before the study starts.
Patients with serious heart problems.
Patients with uncontrolled high blood pressure.
Patients with active infections that need treatment.
Patients who are pregnant or breastfeeding.
Patients with a history of severe allergic reactions to similar medications.
Patients with a condition that affects the immune system, like HIV.
Patients who have had an organ transplant.
Patients who are taking medications that affect the immune system.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
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Marseille, France
Centr Georges Francois Leclerc
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Dijon, France
Centre Leon Berard
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Lyon, France

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Investigated drugs

Pembrolizumab
is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer. Pembrolizumab blocks a specific protein on cancer cells, which allows your immune system to recognize and attack these cells more effectively. In this trial, it is being used to see if it can help control advanced sarcomas, which are a type of cancer that starts in the bones or soft tissues.
Cabozantinib
is a medication that targets certain proteins involved in the growth and spread of cancer cells. It works by blocking these proteins, which can slow down or stop the growth of cancer. Cabozantinib is being tested in this trial to see if it can help manage advanced sarcomas by interfering with the cancer's ability to grow and spread.

What is already known about the treatment

Pembrolizumab
Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced sarcomas, which are a type of cancer. The main therapeutic use of Pembrolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.
Cabozantinib
Cabozantinib is taken orally in the form of a tablet, which means it is swallowed and absorbed through the digestive system. It is being evaluated in clinical trials for its potential to treat advanced sarcomas, a group of cancers. The main therapeutic indication for Cabozantinib is to inhibit the growth of cancer cells and blood vessels that supply tumors. On a molecular level, it works by blocking certain proteins called tyrosine kinases, which are involved in the growth and spread of cancer cells. Cabozantinib is classified as a tyrosine kinase inhibitor, a type of medication that targets specific enzymes involved in cancer cell growth.

Investigated diseases

Undifferentiated Pleomorphic Sarcoma
This is a type of soft tissue sarcoma that lacks a specific line of differentiation, meaning the cells do not resemble any normal tissue. It typically begins as a painless mass in the limbs, often in the thigh or arm. As it progresses, the tumor may grow rapidly and invade surrounding tissues. It can cause swelling and may impair the function of nearby muscles or joints. The disease can spread to other parts of the body, particularly the lungs.
Osteosarcoma
Osteosarcoma is a cancer that originates in the bone-forming cells, most commonly affecting the long bones around the knee. It often presents as localized pain and swelling, which may worsen with activity or at night. As the disease progresses, the affected bone may become weak, leading to fractures. The tumor can grow rapidly, invading nearby tissues and potentially spreading to other areas, such as the lungs.
Ewing Sarcoma
Ewing sarcoma is a rare cancer that typically arises in the bones or soft tissue around the bones, often affecting children and young adults. It usually presents with pain and swelling at the tumor site, which may be accompanied by fever or fatigue. As the disease progresses, the tumor can grow and invade surrounding tissues, potentially causing a palpable mass. It may also spread to other parts of the body, including the lungs and other bones.